Table 2

Primary and secondary efficacy endpoints

RZB 150 mg
N=224
PBO
N=219
Difference
(95% CI)
P value
Primary endpoint
 ACR20 at week 24, n (%)115 (51.3)58 (26.5)24.5 (15.9, 33.0)<0.001*
Ranked secondary endpoints
 Change in HAQ-DI at week 24, mean (95% CI)−0.22 (−0.28 to –0.15)−0.05 (−0.12 to 0.02)−0.16 (−0.26 to 0.07)<0.001*
 PASI 90 at week 24,† n (%)68 (55.0)12 (10.2)44.3 (33.9 to 54.6)<0.001*
 ACR20 at week 16, n (%)108 (48.3)55 (25.3)22.6 (13.9 to 31.2)<0.001*
 MDA at week 24, n (%)57 (25.6)25 (11.4)14.0 (7.0 to 21.0)<0.001*
 Change in SF-36 PCS score at week 24, mean (95% CI)5.9 (4.9 to 6.9)2.0 (0.9 to 3.1)3.9 (2.4 to 5.3)<0.001*
 Change in FACIT-Fatigue score at week 24, mean (95% CI)4.9 (3.7 to 6.0)2.6 (1.4 to 3.9)2.2 (0.6 to 3.9)<0.01*
Non-ranked secondary endpoints
 ACR50 at week 24, n (%)59 (26.3)20 (9.3)16.6 (9.7 to 23.6)<0.001
 ACR70 at week 24, n (%)27 (12.0)13 (5.9)6.0 (0.8 to 11.3)<0.05
 Resolution of enthesitis at week 24,‡ n (%)63 (42.9)48 (30.4)13.8 (3.5 to 24.2)<0.01
 Resolution of dactylitis at week 24,§ n (%)29 (72.5)24 (42.1)38.8 (22.9 to 54.8)<0.001
  • All changes are LS mean changes from baseline.

  • Results for binary endpoints are based on non-responder imputation incorporating multiple imputation if there are missing data due to COVID-19 or non-responder imputation if there are no missing data due to COVID-19. Results for continuous endpoints are based on mixed models for repeated measures.

  • ACR20/50/70, ≥20/50/70% improvement in American College of Rheumatology score; BSA, body surface area; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy–Fatigue Questionnaire; HAQ-DI, Health Assessment Questionnaire–Disability Index; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; LS, least square; MDA, minimal disease activity; PASI 90, ≥90% reduction in Psoriasis Area and Severity Index; PBO, placebo; RZB, risankizumab; SF-36 PCS, 36-Item Short Form Health Survey Physical Component Summary.

  • *Statistically significant under overall type I error control.

  • †Among patients with ≥3% BSA affected by psoriasis at baseline (RZB, n=123; PBO, n=119).

  • ‡Defined as LEI=0 among patients with LEI >0 at baseline (RZB, n=147; PBO, n=158).

  • §Defined as LDI=0 among patients with LDI>0 at baseline (RZB, n=40; PBO, n=57).